Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program, 39880-39882 [2011-17051]
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ATSDR, regarding program goals,
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Prevention, and the Agency for Toxic
Substances and Disease Registry.
Dated: June 30, 2011.
Elizabeth A. Millington,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 2011–16988 Filed 7–6–11; 8:45 am]
BILLING CODE 4163–18–P
Administration for Children and
Families
Announcement of a Grant Award
Office of Community Services,
ACF, HHS.
ACTION: Announcement of the Award of
an Assets for Independence Grant to the
United Way of Abilene, Inc., Abilene,
TX.
AGENCY:
Statutory Authority: Authorized under the
Assets for Independence Act in Title IV of
the Community Opportunities,
Accountability, and Training and
Educational Services Human Services
Reauthorization Act of 1998, Public Law
105–285, as amended.
The Administration for
Children and Families (ACF), Office of
Community Services (OCS), Division of
Community Demonstration Programs
announces the award of an Assets for
Independence (AFI) demonstration
grant to the United Way of Abilene, Inc.
of Abilene, TX in the amount of
$61,149.
The purpose of this award is to enable
the United Way of Abilene, Inc. to
implement an Assets for Independence
(AFI) project helping program
participants save earned income in
special-purpose, matched savings
accounts called Individual Development
Accounts (IDAs). Every dollar in savings
deposited into an IDA by participants is
matched, from $1 to $8 combined
Federal and non-Federal funds,
promoting savings and enabling
participants to acquire a lasting
economic asset. AFI project families use
SUMMARY:
Fmt 4703
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James Gatz, Program Manager, Assets for
Independence, Office of Community
Services, Administration for Children
and Families, U.S. Department of Health
and Human Services, 901 D Street, SW.,
5th floor East, Washington, DC 20047.
Telephone: 202–401–5284; E-mail:
james.gatz@acf.hhs.gov.
Dated: June 23, 2011.
Lynda E. Perez,
Acting Director, Division of Community
Demonstration Programs, Office of
Community Services.
[FR Doc. 2011–16973 Filed 7–6–11; 8:45 am]
BILLING CODE 4184–26–P
CFDA Number: 93.602.
Frm 00070
The project period for this award
is November 1, 2010 through September
29, 2011.
DATES:
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PO 00000
their IDA savings, including the
matching funds, to achieve any of three
objectives: acquiring a first home;
capitalizing a small business; or
enrolling in postsecondary education or
training.
Additionally, the United Way of
Abilene, Inc. provides basic financial
management training and supportive
services, such as financial education on
owning and managing a bank account;
credit counseling and repair; guidance
in accessing refundable tax credits,
including the Earned Income Tax Credit
and the Child Tax Credit; and
specialized training in owning
particular economic assets for the long
term.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0226]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Draft Guidance for
Industry, Third Parties and Food and
Drug Administration Staff; Medical
Device ISO 13485:2003 Voluntary Audit
Report Submission Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995
(PRA).
SUMMARY:
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Federal Register / Vol. 76, No. 130 / Thursday, July 7, 2011 / Notices
Fax written comments on the
collection of information by August 8,
2011.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW and
title ‘‘Draft Guidance for Industry, Third
Parties and Food and Drug
Administration Staff; Medical Device
ISO 13485:2003 Voluntary Audit Report
Submission Program’’. Also include the
FDA docket number found in brackets
in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
DATES:
Draft Guidance for Industry, Third
Parties and Food and Drug
Administration Staff; Medical Device
ISO 13485:2003 Voluntary Audit
Report Submission Program—(OMB
Control Number 0910)–NEW
Under the PRA (44 U.S.C. 3501–
3520), Federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, in the Federal Register of
May 20, 2010 (75 FR 28257), FDA
published a notice of availability of the
draft guidance document providing a
60-day public comment period on the
proposed collection of information
provisions.
Title: Draft Guidance for Industry,
Third Parties and FDA Staff: Medical
Device ISO 13485:2003 Voluntary Audit
Report Submission Program.
Description: Section 228 of the Food
and Drug Administration Amendments
Act of 2007 (FDAAA), amended section
704(g)(7) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 374(g)(7)) to
add the following provision: ‘‘(F) For
the purpose of setting risk-based
inspectional priorities, the Secretary
shall accept voluntary submissions of
reports of audits assessing conformance
with appropriate quality system
standards set by the International
Organization for Standardization (ISO)
and identified by the Secretary in public
notice. If the owner or operator of an
establishment elects to submit audit
reports under this subparagraph, the
owner or operator shall submit all such
audit reports with respect to the
establishment during the preceding 2year periods.’’
The ‘‘Draft Guidance for Industry,
Third Parties and FDA Staff: Medical
Device ISO 13485:2003 Voluntary Audit
Report Submission Program’’ will
describe how FDA’s Center for Devices
and Radiological Health and Center for
Biologics Evaluation and Research are
implementing this provision of the law
and providing public notice as required.
The proposed collections of information
are necessary to satisfy the previously
mentioned statutory requirements for
implementing this voluntary submission
program.
Based on FDA’s experience with the
founding regulatory members of the
Global Harmonization Task Force
(GHTF), FDA expects that the vast
majority of manufacturers who will
participate in the Voluntary Audit
Report Submission Program will be
manufacturers who are certified by
Health Canada under ISO 13485:2003.
In 2008, approximately 2,650
manufacturers or manufacturing sites
had been certified by Health Canada.
The majority of these manufacturers are
also certified under ISO 13485:2003 by
the European Union Notified Body
accreditation system.
In addition, FDA only expects firms
that do not have major deficiencies or
observations in their ISO 13485:2003
audits to be willing to submit their audit
reports to FDA under the Voluntary
Audit Report Submission Program. FDA
analyzed its inspection data from Fiscal
Year (FY) 2008 (October 1, 2007 to
October 1, 2008) and determined that
the total number of inspections finalized
in FY2008 for medical devices was
1,965. The breakdown for the 1,965
compliance decisions is as follows:
TABLE 1—COMPLIANCE DECISION BREAKDOWN
Compliance decision
Number
Official Action Indicated .....................................................................................................................................................
Voluntary Action Indicated .................................................................................................................................................
No Action Indicated ...........................................................................................................................................................
Pending Final Decision ......................................................................................................................................................
148
775
1,025
17
Approximate
percentage
(%)
8
40
52
1
sroberts on DSK5SPTVN1PROD with NOTICES
1 June 15, 2006, Compliance Program 7382.845 Inspection of Medical Device Manufacturers Part V https://www.fda.gov/cdrh/comp/guidance/
7382.845.html#p5p5.pdf.
Because FDA only expects firms who
do not have major deficiencies or
observations to be willing to submit
their audit reports to FDA under the
Voluntary Audit Report Submission
Program, FDA only expects to receive
audit reports that would have been
classified by FDA as No Action
Indicated (NAI).
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Assuming that the percentage
breakdown of compliance decisions for
all inspections conducted in FY2008
can be extrapolated and applied to
audits of manufacturers certified under
ISO 13485:2003 by Health Canada, FDA
can estimate the number of Canadian
establishments that would have had an
inspection classified as an NAI. Because
52 percent of all compliance decisions
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
resulted in an NAI decision, FDA
estimates that 1,378 of the facilities
certified under ISO 13485:2003 by
Health Canada (52 percent of the total
2,650 facilities) would have had an
inspection classified as an NAI. Because
FDA only expects to receive audit
reports that would have been classified
by FDA as NAI, FDA expects 1,378, or
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Federal Register / Vol. 76, No. 130 / Thursday, July 7, 2011 / Notices
approximately 1,400, audit reports to be
submitted.
Because FDA expects that the vast
majority of manufacturers who will
participate in the Voluntary Audit
Report Submission Program will be
manufacturers certified by Health
Canada under ISO 13485:2003, FDA
expects the number of reports to be
submitted from manufacturers certified
by regulatory systems established by
other founding GHTF members to be
minimal. For purposes of calculating the
reporting burden, FDA estimates that
approximately 10 percent of total audit
reports submitted under this program
will be from these other manufacturers.
Because 90 percent of the audit reports
are expected to be submitted by
manufacturers certified by Health
Canada (approximately 1,400 audit
reports as calculated previously in this
document), the total number of audit
reports FDA expects to receive in a year
is 1,556, or approximately 1,600 audit
reports.
FDA estimates from past experience
with the Electronic Submission Gateway
system, WebTrader, that the first year to
set up the account and to receive the
verification certificate takes
approximately 40 hours. This burden
may be minimized if the Respondent
already has an established account in
WebTrader for other electronic
submissions to FDA but FDA is
assuming that all respondents to this
new pilot program will be setting up a
WebTrader account for the first time in
the first year. For subsequent years, the
estimate burden hours are estimated at
1 hour to renew the yearly required
verification certification.
FDA further estimates that the
gathering, scanning, and submission of
the audit reports, certificates, and
related correspondence would take
approximately 2 hours utilizing the
eSubmitter system.
Therefore, the first year will include
40 hours for the WebTrader system plus
2 hours for the eSubmitter submission
process, resulting in 42 hours per
response for the first year. For both the
second and third years, it is estimated
that only 1 hour will be necessary for
the WebTrader system plus the 2 hours
for the eSubmitter submission process,
resulting in 3 hours per response each
year thereafter.
The draft guidance also refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by OMB under the
PRA. The collections of information in
21 CFR part 820 have been approved
under OMB control number 0910–0073
and the collections of information for
the Inspection by Accredited Persons
Program have been approved under
OMB control number 0910–0569.
In the Federal Register of May 20,
2010 (75 FR 28257), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received one
comment which was related to the PRA
reporting burden.
The comment stated that the reporting
burden hours may be too low for the
first submission and may take less time
for subsequent submissions. In addition,
this comment stated that the number of
reports anticipated to be submitted may
be a high estimate by a factor of 10. FDA
appreciates the consideration of burden
hours by the comment. The comment,
however, did not provide any data to
assist FDA to adjust the burden hours
for the submission. Absent baseline
information at this time, FDA will
review the submissions during the pilot
period and modify the burden to
respondents accordingly.
FDA estimates the burden of this
collection of information as follows:
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN
No. of
responses per
respondent
per year
No. of
respondents
Average
burden per
response
(in hours)
Total annual
responses
Total hours
Capital and
operating and
maintenance
costs
First year ................................................
Second year (recurring) .........................
Third year (recurring) .............................
1,600
1,600
1,600
1
1
1
1,600
1,600
1,600
142
3
3
67,200
4,800
4,800
2,016,000
48,000
48,000
Totals ..............................................
........................
........................
........................
........................
76,800
2,112,000
1Respondent
may already have a valid WebTrader account established for other FDA electronic submissions.
There are capital, start-up, operating,
or maintenance cost associated with this
information collection. The costs are
$30 per year to establish and maintain
the Electronic Submission Gateway
verification certificate.
Dated: July 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0478]
General and Plastic Surgery Devices
Panel of the Medical Devices Advisory
Committee; Notice of Meeting
[FR Doc. 2011–17051 Filed 7–6–11; 8:45 am]
AGENCY:
BILLING CODE 4160–01–P
Food and Drug Administration,
sroberts on DSK5SPTVN1PROD with NOTICES
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
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PO 00000
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Name of Committee: General and
Plastic Surgery Devices Panel of the
Medical Devices Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on August 30 and 31, 2011, from
8 a.m. to 6 p.m.
Addresses: FDA is opening a docket
for public comment on this document.
The docket will open for public
comment on July 7, 2011. The docket
will close on August 26, 2011.
Interested persons may submit
electronic or written comments
regarding this document. Submit
electronic comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
E:\FR\FM\07JYN1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 130 (Thursday, July 7, 2011)]
[Notices]
[Pages 39880-39882]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17051]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0226]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Draft Guidance for
Industry, Third Parties and Food and Drug Administration Staff; Medical
Device ISO 13485:2003 Voluntary Audit Report Submission Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995 (PRA).
[[Page 39881]]
DATES: Fax written comments on the collection of information by August
8, 2011.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-NEW and
title ``Draft Guidance for Industry, Third Parties and Food and Drug
Administration Staff; Medical Device ISO 13485:2003 Voluntary Audit
Report Submission Program''. Also include the FDA docket number found
in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Draft Guidance for Industry, Third Parties and Food and Drug
Administration Staff; Medical Device ISO 13485:2003 Voluntary Audit
Report Submission Program--(OMB Control Number 0910)-NEW
Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain
approval from the Office of Management and Budget (OMB) for each
collection of information they conduct or sponsor. ``Collection of
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and
includes agency requests or requirements that members of the public
submit reports, keep records, or provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires
Federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information before submitting
the collection to OMB for approval. To comply with this requirement, in
the Federal Register of May 20, 2010 (75 FR 28257), FDA published a
notice of availability of the draft guidance document providing a 60-
day public comment period on the proposed collection of information
provisions.
Title: Draft Guidance for Industry, Third Parties and FDA Staff:
Medical Device ISO 13485:2003 Voluntary Audit Report Submission
Program.
Description: Section 228 of the Food and Drug Administration
Amendments Act of 2007 (FDAAA), amended section 704(g)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(g)(7)) to add the
following provision: ``(F) For the purpose of setting risk-based
inspectional priorities, the Secretary shall accept voluntary
submissions of reports of audits assessing conformance with appropriate
quality system standards set by the International Organization for
Standardization (ISO) and identified by the Secretary in public notice.
If the owner or operator of an establishment elects to submit audit
reports under this subparagraph, the owner or operator shall submit all
such audit reports with respect to the establishment during the
preceding 2-year periods.''
The ``Draft Guidance for Industry, Third Parties and FDA Staff:
Medical Device ISO 13485:2003 Voluntary Audit Report Submission
Program'' will describe how FDA's Center for Devices and Radiological
Health and Center for Biologics Evaluation and Research are
implementing this provision of the law and providing public notice as
required. The proposed collections of information are necessary to
satisfy the previously mentioned statutory requirements for
implementing this voluntary submission program.
Based on FDA's experience with the founding regulatory members of
the Global Harmonization Task Force (GHTF), FDA expects that the vast
majority of manufacturers who will participate in the Voluntary Audit
Report Submission Program will be manufacturers who are certified by
Health Canada under ISO 13485:2003. In 2008, approximately 2,650
manufacturers or manufacturing sites had been certified by Health
Canada. The majority of these manufacturers are also certified under
ISO 13485:2003 by the European Union Notified Body accreditation
system.
In addition, FDA only expects firms that do not have major
deficiencies or observations in their ISO 13485:2003 audits to be
willing to submit their audit reports to FDA under the Voluntary Audit
Report Submission Program. FDA analyzed its inspection data from Fiscal
Year (FY) 2008 (October 1, 2007 to October 1, 2008) and determined that
the total number of inspections finalized in FY2008 for medical devices
was 1,965. The breakdown for the 1,965 compliance decisions is as
follows:
Table 1--Compliance Decision Breakdown
------------------------------------------------------------------------
Approximate
Compliance decision Number percentage (%)
------------------------------------------------------------------------
Official Action Indicated..................... 148 8
Voluntary Action Indicated.................... 775 40
No Action Indicated........................... 1,025 52
Pending Final Decision........................ 17 1
------------------------------------------------------------------------
\1\ June 15, 2006, Compliance Program 7382.845 Inspection of Medical
Device Manufacturers Part V https://www.fda.gov/cdrh/comp/guidance/7382.845.html#p5p5.pdf.
Because FDA only expects firms who do not have major deficiencies
or observations to be willing to submit their audit reports to FDA
under the Voluntary Audit Report Submission Program, FDA only expects
to receive audit reports that would have been classified by FDA as No
Action Indicated (NAI).
Assuming that the percentage breakdown of compliance decisions for
all inspections conducted in FY2008 can be extrapolated and applied to
audits of manufacturers certified under ISO 13485:2003 by Health
Canada, FDA can estimate the number of Canadian establishments that
would have had an inspection classified as an NAI. Because 52 percent
of all compliance decisions resulted in an NAI decision, FDA estimates
that 1,378 of the facilities certified under ISO 13485:2003 by Health
Canada (52 percent of the total 2,650 facilities) would have had an
inspection classified as an NAI. Because FDA only expects to receive
audit reports that would have been classified by FDA as NAI, FDA
expects 1,378, or
[[Page 39882]]
approximately 1,400, audit reports to be submitted.
Because FDA expects that the vast majority of manufacturers who
will participate in the Voluntary Audit Report Submission Program will
be manufacturers certified by Health Canada under ISO 13485:2003, FDA
expects the number of reports to be submitted from manufacturers
certified by regulatory systems established by other founding GHTF
members to be minimal. For purposes of calculating the reporting
burden, FDA estimates that approximately 10 percent of total audit
reports submitted under this program will be from these other
manufacturers. Because 90 percent of the audit reports are expected to
be submitted by manufacturers certified by Health Canada (approximately
1,400 audit reports as calculated previously in this document), the
total number of audit reports FDA expects to receive in a year is
1,556, or approximately 1,600 audit reports.
FDA estimates from past experience with the Electronic Submission
Gateway system, WebTrader, that the first year to set up the account
and to receive the verification certificate takes approximately 40
hours. This burden may be minimized if the Respondent already has an
established account in WebTrader for other electronic submissions to
FDA but FDA is assuming that all respondents to this new pilot program
will be setting up a WebTrader account for the first time in the first
year. For subsequent years, the estimate burden hours are estimated at
1 hour to renew the yearly required verification certification.
FDA further estimates that the gathering, scanning, and submission
of the audit reports, certificates, and related correspondence would
take approximately 2 hours utilizing the eSubmitter system.
Therefore, the first year will include 40 hours for the WebTrader
system plus 2 hours for the eSubmitter submission process, resulting in
42 hours per response for the first year. For both the second and third
years, it is estimated that only 1 hour will be necessary for the
WebTrader system plus the 2 hours for the eSubmitter submission
process, resulting in 3 hours per response each year thereafter.
The draft guidance also refers to previously approved collections
of information found in FDA regulations. These collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 820 have been approved under OMB control
number 0910-0073 and the collections of information for the Inspection
by Accredited Persons Program have been approved under OMB control
number 0910-0569.
In the Federal Register of May 20, 2010 (75 FR 28257), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one comment which was related
to the PRA reporting burden.
The comment stated that the reporting burden hours may be too low
for the first submission and may take less time for subsequent
submissions. In addition, this comment stated that the number of
reports anticipated to be submitted may be a high estimate by a factor
of 10. FDA appreciates the consideration of burden hours by the
comment. The comment, however, did not provide any data to assist FDA
to adjust the burden hours for the submission. Absent baseline
information at this time, FDA will review the submissions during the
pilot period and modify the burden to respondents accordingly.
FDA estimates the burden of this collection of information as
follows:
Table 2--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Capital and
No. of responses per Total annual Average burden operating and
respondents respondent per responses per response Total hours maintenance
year (in hours) costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
First year............................................. 1,600 1 1,600 \1\42 67,200 2,016,000
Second year (recurring)................................ 1,600 1 1,600 3 4,800 48,000
Third year (recurring)................................. 1,600 1 1,600 3 4,800 48,000
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Totals............................................. .............. .............. .............. .............. 76,800 2,112,000
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\1\Respondent may already have a valid WebTrader account established for other FDA electronic submissions.
There are capital, start-up, operating, or maintenance cost
associated with this information collection. The costs are $30 per year
to establish and maintain the Electronic Submission Gateway
verification certificate.
Dated: July 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-17051 Filed 7-6-11; 8:45 am]
BILLING CODE 4160-01-P
